IRCT20101012004920N11尚未招募3 期
Comparison the efficacy and safety of botulinum toxin type A of Plasma Darman Sarve Sepid Company with Dysport® of Ipsen Co. in the treatment of the moderate to severe glabellar lines: a randomized, active controlled, double-blind, non-inferiority phase 3 trial
Plasma Darman Sarve Sepid Company0 个研究点目标入组 202 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 202
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 25 years 至 55 years（—）
- 性别
- All
入选标准
- •Both genders
- •Age between 25- 55 years old
- •General health condition by medical history and physical examination
- •Moderate to severe Glabellar lines by GLS and GLSS criteria
- •Informed consent to participate in the study
排除标准
- •Conditions that alter the safety results, like: eyelid ptosis or eyebrow ptosis; facial nerve paralysis; notable face asymmetry; overt dermatochalasis; deep dermal scar; thick sebaceous skin
- •Neuromuscular junction diseases i.e. Myasthenia Gravis; Eaton Lembert syndrome; Amyotrophic Lateral Sclerosis or other disease that alter neuromuscular function
- •Sever muscular atrophy or weakness in injection site
- •Previous injection of Botulinum neurotoxin in last 6 months
- •Participation in other trials related to Botulinum neurotoxin and fillers
- •History for hypersensitivity reaction to filler or gel injection or laser therapy in face area
- •History for Filler or gel injection in face
- •History for face plastic surgery i.e. tissue augmentation, eyebrow lifting or dermal resurfacing
- •History for cosmetic surgery (chemical peeling, laser) using materials that cause skin remodeling or active changes in forehead and near area (in 6 months).
- •History for eyebrow tattoo or other procedure in last month
- •History for insertion unabsorbable material or surgery to remove Corrugator? Procerus? Supercilli Depressor or combination therapy
- •Previous hypersensitivity or sever event after similar botulinum neurotoxin administration
- •Previous scar or surgery in eyebrow or forehead
- •Acute infection or dermal disease in injection site
- •Sever cardiovascular, respiratory disease or asthma
- •Planned cosmetic surgery during study
- •Intention to participate in other trial during study
- •Taking medications i.e. for Alzheimer disease (galantamine, rivastigmine, tacrine), Myasthenia gravis (ambenonium, pyridostigmine) and anticoagulants (warfarin, aspirin)
- •Taking medications: Aminoglycosides (gentamycin, ...), penicillamine, quinine, chloroquine, hydroxychloroquine, Calcium channel blockers one week before study
- •Pregnancy or breast feeding
- •Unwillingness to participate in the study
- •Not regularly participate in clinical visits and evaluations
- •Participate in any other clinical trial during the study
- •Happening sever hypersensitivity reactions related to botulinum neurotoxin till 30 minutes after injection
- •Happening serious unwanted event that participant needs to exit study by investigator's decision
- •Happening new or chronic condition that participant needs to exit study by investigator's decision
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